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Case Study: Ensuring Traceability and Transparency in the Development of eClinical Solutions

DATATRAK is a leading eClinical solutions company that saw significant benefits from making the transition to integrated Application Lifecycle Management. Read on for insights from Intland's case study about DATATRAK to find out what they gained from switching to codebeamer!

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About DATATRAK

DATATRAK International, Inc. provides software solutions and services that safely accelerate clinical research. Since its founding in 1995, DATATRAK has developed a complete portfolio of cloud-based software for drug and device studies. Companies around the world use the DATATRAK Enterprise unified platform.

Looking for Traceability

DATATRAK develops software that complies with specific FDA regulations. Complete traceability and transparency of processes are critical for compliance.

Before making the switch to ALM, DATATRAK was using a basic ticketing system to track their internal processes. The system had limited workflow capabilities. Connecting various pieces of information and tracking actions related to them was difficult.

The company had poor visibility into their processes.

DATATRAK decided to implement a full Application Lifecycle Management (ALM) application in April 2011. They hoped to increase process visibility and traceability. They wanted a centralized location to manage all work items and stages of the product lifecycle.

Find out more:

DATATRAK: A Success Story of Traceability and Process Transparency

Why DATATRAK chose codebeamer?

DATATRAK evaluated several systems and chose the codebeamer ALM platform. The company based this choice on several criteria:

Integrated Solution

One of DATATRAK's main requirements was to have an integrated, centralized software solution. The company needed end-to-end functionality.

codebeamer is designed to provide that type of integrated functionality. A single repository stores all your artifacts and lifecycle data. Design and development processes are aligned, and smooth collaboration across teams is easily ensured. With codebeamer, managing the impact of changes across the lifecycle is efficient and accurate.

Traceability and Process Visibility

codebeamer's centralized data repository guarantees complete traceability across all work items. The repository stores relationships between work items and establishing these links is easily automated. DATATRAK now benefits from end-to-end traceability throughout the product lifecycle, from the requirements stage all the way through testing and release.

codebeamer's Traceability Browser provides a simple and efficient way to overview relationships between work items. You can easily filter the browser to get only the items you need – at compliance audits like the ones DATATRAK faces, this is a vital capability.

In addition, a Test Coverage Browser is also available to help ensure that test cases cover all the requirements.

QA Audits and Compliance

DATATRAK needs to ensure FDA compliance for its software solution. The company found codebeamer's advanced audit capabilities to be a big advantage.

QA audits on software products require deep version control integration. Users of codebeamer enjoy full traceability on code reviews and other development artifacts.

The Mercurial integration in codebeamer has given DATATRAK greater functionality than the company saw in other products.

DATATRAK depends on codebeamer's built-in Traceability Browser, Test Coverage Browser, custom Wiki plugins, and custom workflows. These features facilitate compliance audits. codebeamer makes it easier to enforce the use of mature processes and to report on process quality at audits.

Customizable Workflows

DATATRAK greatly benefits from codebeamer's flexibility. Using codebeamer, you can configure workflows to support internal needs and development processes, regardless of their complexity. This is one of the platform's key strengths, as your teams won't be limited by their toolset – instead, they can adapt the platform to their needs.

In addition to customizable workflows, codebeamer allows the customization of tracker artifacts. Users can also apply special, custom-configured workflows to these updated trackers, allowing optimal flexibility.

For example, DATATRAK added risk and impact analysis data to their Change Request trackers. All involved parties can review change requests and make more informed approval decisions.

Document Management

codebeamer has a built-in document management tool. DATATRAK customized it to meet their needs in complying with specific industry standards.

The company can apply custom reviewer and approval workflows. The development team can use this tracker to process all system document signatures. The process is more efficient and moves more quickly.

Ease of Use

DATATRAK appreciated how easy codebeamer was to roll out. The application is simple to learn and intuitive to use, with a user-friendly, intuitive interface. Teams can realize value with codebeamer from day 1.

Total Cost of Ownership

DATATRAK found that the Total Cost of Ownership for codebeamer made it a better choice than the other tools under consideration. codebeamer is affordable and offers excellent value for product teams, contributing to a faster return on investment.

DATATRAK has been steadily expanding the number of users for codebeamer. The company has seen increased value with the increased expansion. More and more members of several departments are benefiting from using integrated ALM.

Interested in learning more about DATATRAK's use case? Find all the details in the full case study!

Benefits of Integrated ALM for eClinical Solutions

An integrated Application Lifecycle Management platform provides many benefits for developers of life sciences technology. Product design & development processes are easily controlled, streamlined, and reported on. The time and effort costs of audit preparation are greatly reduced.

DATATRAK saw immediate value from optimizing requirement tracking and approvals with codebeamer. The company made significant improvements to its test case review and approval tracking processes. Another important benefit is software-based tracking and approvals of incident reports, system change control, document approvals, and signoffs.

Be the Next Case Study

DATATRAK continues to reap the rewards of their transition to codebeamer. Your company can be next. If you're looking to improve traceability and transparency in your processes, an integrated ALM system could be the answer.

codebeamer X for MedTech Development

Since this DATATRAK case study was published, Intland Software designed a new solution specifically for life sciences companies.

codebeamer X is an Engineering Lifecycle Management (ELM) platform that supports the development of software-driven products in life sciences industries. Medical device developers, pharmaceutical companies, and other innovators use codebeamer X to break down silos along the lifecycle, to support collaboration, and cut the costs of compliance audits.

Learn more about codebeamer X!

For MedTech developers, codebeamer X extends traditional ALM functionality with regulatory process templates, quality management, and review boards. All this comes in an integrated platform that MedTech product teams can adapt to their internal processes and needs.

Find out how codebeamer X helps make products faster, more cost-effectively, and in higher quality! Contact us to learn more, or try the tool for 30 days – no strings attached.

Try codebeamer X now

Start your online trial of codebeamer X. It only takes a minute, and you won’t have to download anything.